The worldwide eClinical solutions market, currently estimated at $3 billion per year, is expected to grow to a staggering $5.98 billion per year by 2020 according to a report by the analyst firm MarketsAndMarkets. The fastest growing segment of this market is eCOA (electronic Clinical Outcomes Assessment) solutions, also known as ePRO (electronic Patient Reported Outcomes), which is currently estimated at over $500 million per year.
So what is driving this explosive growth in eCOA solutions? First, regulatory authorities such as the FDA are encouraging the collection of outcomes data and providing specific guidance (see Guidance for Industry, Electronic Source Data in Clinical Investigations). Second, payers are increasingly requiring evidence of efficacy post approval before agreeing to pay for treatments. Finally, the rapidly changing technology landscape with the proliferation of handhelds and wearables has made electronically capturing outcomes data from patients not only practical, but also relatively easy.
Even though the eCOA solutions market is already sizable, current solutions are far from exploiting what is possible. While the solutions in the market today have effectively replaced paper-based patient diaries with electronic versions, they haven’t been able to fundamentally change patients’ role and participation in clinical trials. However, there is evidence that the industry is getting past the initial adoption hurdles and starting to focus on the benefits of technology as evidenced by a recent report by ERT: eCOA Increases Patient-Site Communication and Candor.
While clinical trials as a whole are in a need for transformation (see my article on Clinical Trial Transformation), eCOA solutions are ripe for a technology upgrade. Here are seven technology trends that will revolutionize eCOA solutions in the coming years.
Consumerization of IT in the enterprise – where users bring their own computing devices and use some of the same applications they use in their personal lives – has been underway for many years now. Consumerization of user experience – enterprise software evolving to deliver a user experience that is similar to what they experience in consumer applications – has the potential of making the eCOA solutions significantly easier for patients and sites. A large eCOA trial typically involves tens of thousands of users and can last for years. Reduced training and on-boarding costs and improved engagement can have a significant positive impact on the trial.
While pharmaceutical companies are not early adopters of technology, the move to the cloud in pharma and multi-tenant SaaS is well underway, led by the life sciences-focused cloud solution provider Veeva. Veeva entered the market with a multi-tenant cloud solution for pharma sales & marketing, but is now showing equally impressive growth in pharma R&D with its Vault product. eCOA solutions with a large patient user base are naturally suited for a move to the cloud. Remember, consumer solutions are invariably cloud-based!
Providing real-time insights and feedback always improves usability but it becomes even more important when engaging with a large user base of sponsors, sites and patients. Consumer health apps such as Nike+ provide continuous feedback to users to increase engagement. As I wrote earlier on gamification in clinical trials, real-time updates combined with some element of gamification can significantly increase patient engagement and overall usability and effectiveness of the entire solution.
Mobile is already the predominant mode for patient data entry (ePRO) even though most of these devices are provided by the sponsors to patients (see BYOD below for more on this) but usage of mobile and tablet for raters and study administrators is still limited. A recent survey of 1500 clinical trial site contacts by Worldwide Clinical Trials indicated that investigators still prefer paper over electronic entry due to perceived interference with patient rapport. Tablets and mobile devices will eventually replace the clipboard. Solution providers need to continue to improve the usability of these devices.
On average about a third of the eCOA solution cost is for supplying provisioned devices (mobile phones with eCOA software preinstalled) to patients participating in a trial, therefore using a BYOD strategy could reduce costs significantly. However, cost savings alone is not enough of a reason for a switch and perhaps explains why adoption of BYOD has been slow to date.
Instead focusing on the benefits of BYOD such as improved patient engagement (using the device they already carry is easier) and better compliance (again, due to not having to carry a second device) makes more sense. Solutions such as Xamarin make it much easier to build native applications for multiple devices. Microsoft recently purchased Xamarin and made it available to its customers at no additional cost, thereby making multiple device support less expensive for companies using tools based on the Microsoft platform.
Wearables market grew 171% to 78.1 million units in 2015 according to a report by IDC. Wearable health trackers such as Fitbit and Jawbone have become mainstream and are no longer limited to technophiles and early adopters, according to the firm. However, there are broader consumer and industry trends transforming the health and activity tracking landscape:
There is no doubt that technology in healthcare has become one of the greatest frontiers for invention, as various aspects of science are coming together to create new and amazing devices to improve health and wellness. The question today about device integration is “why not” instead of “why”. With that said, sponsors still need to carefully evaluate the devices and design trials appropriately when integrating devices in clinical trials (see Are Wearables Fit for Clinical Trials by Gartner).
Big data is impacting virtually every industry today. Data is being collected in countless ways (every day there is 2.5 quintillion bytes of new data) and being used in new and unpredictable ways (Foursquare recently predicted a 30% decline in Chipotle’s revenue based on the decline in foot traffic to Chipotle stores). In eCOA solutions, wearables will create large data sets of new data about patients’ health, mobility, activities, and safety and efficacy of treatment. Additionally, big data could be used for study design and patient or investigator selection to find the best match for specific trials.